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DIRECTA AB

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80309383004586882DIRECTA AB1N2027-01-01PO BOX 723 FINVIDS VAG 8 UPPLANDS VAESBY Stockholm SE 194 27

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
17310231029993ProphyCare HAp - ProphyCare HAp in single dose disposable cups+46850650575info@directadental.com
17310236901089ProphyCare HAp - ProphyCare HAp in single dose disposable cups+46850650575info@directadental.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
132071687380615K895508CALASEPT PASTEEJK1989-12-08
132071230397933K241131edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCKEBF2024-10-18
132071879041138K202413LC ResinCal PCEJK2020-11-20
132071443001560K170175ENDOSEAL MTAKIF2018-02-26
132071944028033K133178LUXATOR LX HANDPIECEEGS2015-11-24
132071310874505K113040CERAMIR CROWN & BRIDGEEMA2011-12-28
132071721289194K112078ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)KIF2012-03-19
132071741453863
132071040811638
132071107390441
132071125885562
132071148919920
132071161888763
132071210659014
132071247412898
132071335536563
132071352544099
132071360205071
132071361590390
132071375685919
132071416777240
132071487082165
132071494202917
132071555515616
132071593409596
132071627103101
132071707547142
132071730365946
132071781123419
132071844845888
132071859446227
132071880005403
132071882306179
132071919686248
132071923031627
132072022390010
132072035407551

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EJK22020-11-20
KIF22018-02-26
EBF12024-10-18
EGS12015-11-24
EMA12011-12-28

PMN#

GUDID#

200 records. Showing 1-40. Next